EP3531913B1 - Verfahren zur bestimmung einer analytkonzentration in einer körperflüssigkeit und analytkonzentrationsmessvorrichtung - Google Patents

Verfahren zur bestimmung einer analytkonzentration in einer körperflüssigkeit und analytkonzentrationsmessvorrichtung Download PDF

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Publication number
EP3531913B1
EP3531913B1 EP17793905.5A EP17793905A EP3531913B1 EP 3531913 B1 EP3531913 B1 EP 3531913B1 EP 17793905 A EP17793905 A EP 17793905A EP 3531913 B1 EP3531913 B1 EP 3531913B1
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Prior art keywords
test element
measuring
body portion
proximity sensor
measuring values
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English (en)
French (fr)
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EP3531913A1 (de
Inventor
Volker Huellen
Max Berg
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F Hoffmann La Roche AG
Roche Diabetes Care GmbH
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F Hoffmann La Roche AG
Roche Diabetes Care GmbH
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483—Physical analysis of biological material
    • G01N33/487—Physical analysis of biological material of liquid biological material
    • G01N33/48785—Electrical and electronic details of measuring devices for physical analysis of liquid biological material not specific to a particular test method, e.g. user interface or power supply
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/0045—Devices for taking samples of body liquids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0059—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
    • A61B5/14551—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters for measuring blood gases
    • A61B5/14552—Details of sensors specially adapted therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0257—Proximity sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15101—Details
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/157—Devices characterised by integrated means for measuring characteristics of blood
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
    • G01N21/77—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
    • G01N21/78—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator producing a change of colour

Definitions

  • the invention concerns a method for determination of an analyte concentration in a body fluid.
  • the invention further concerns an analyte concentration measurement device.
  • test elements can be provided as chemistry fields on a test tape, which is loadable into the meter in the form of a replaceable tape cassette.
  • the user has no need to take care of the disposal of each single test element.
  • the instrument is generally used by patients outside a laboratory environment, and therefore the measurement may be susceptible to non-intended user handling. In extreme cases of user handling scenarios, significant measurement deviations may occur.
  • a proximity sensor module is configured to detect the presence of a user's body in order to switch the meter from standby to active mode.
  • US 2015/0238131 A1 proposes to employ a proximity sensor to determine whether a body part of a user protrudes by a required amount within a housing aperture such that a lancing and blood collecting operation will be successful with a high degree of confidence.
  • This document is not concerned with instrument handling during the ultimate measurement procedure, as the sample handling and processing is carried out in a fully automated way inside the housing.
  • the object of the invention is to further improve the known measuring methods and systems to enhance the accuracy and precision of the measurement results by controlled user handling during the data acquisition phase or detection phase.
  • the invention is based on the idea of preventing measurements from being distorted by the presence of a body part.
  • a method for determination of an analyte and specifically glucose in a body fluid is proposed according to the invention which comprises the steps of:
  • a warning is provided to the user upon sensing the presence of the body portion in the monitored space. Such a warning may contribute to optimization of user handling.
  • Another improvement in this direction provides for measuring a time interval of presence of the body portion in the monitored space, and for aborting the detection of measuring values and/or providing an error message to the user after a predetermined length of the time interval.
  • a wetting of the test element with body fluid is detected, and measuring of the time interval is started at the point in time when detecting the wetting.
  • the length of the time interval is in the range of 0,5 to 2 s.
  • the detection of measuring values is completed only if the body portion is not present in the monitored space.
  • the output signal of the proximity sensor is made available as an input for a processor unit of the meter during processing of the measuring values.
  • the proximity sensor For a dedicated discrimination of a problematic proximity it is advantageous to configure the proximity sensor such that the monitored space includes a cuboid in the size of at least 1 x 1 x 5 mm, preferably at least 3 x 3 x 10 mm, where the long side of the cuboid is perpendicular to a surface of the test element.
  • the output signal of the proximity sensor is provided as a digital value indicating solely the presence or absence of the body portion in the monitored space.
  • the detection of measuring values comprises an initial measuring phase for measuring a blank value on the test element prior to body fluid application, an intermediate measuring phase for tracking a development of the measuring values, and a final measuring phase for determining an end value which is characteristic for a quantity of the analyte.
  • a further improvement in this connection comprises transporting the test element on a transport tape over a deflection tip as a sample application site, and arranging the proximity sensor adjacent or in close proximity to the deflection tip.
  • a still further improvement provides that the body fluid is applied on a freely accessible application side of the test element, and the measuring values are detected by scanning a back side of the test element opposite to the application side.
  • an analyte concentration measurement device in particular for blood glucose determination, comprising a handheld meter adapted to provide a disposable test element having a reaction area at an application site for applying body fluid from a user's body portion, a preferably photometric detection unit operable for detecting measuring values on or from the reaction area of the test element, and a proximity sensor disposed within the meter to sense the presence of the body portion in a monitored space in proximity to the reaction area of the test element, wherein a processor unit of the meter is configured for
  • FIG. 1 an exemplary embodiment of a medical analyte testing system for testing an analyte in a body fluid, specifically glucose in a blood sample is shown.
  • the system 10 at least comprises a portable blood glucose meter 12 adapted to receive a disposable test tape cassette 14 (shown separately) which can be inserted into a compartment of the meter 12.
  • a tip 16 of the inserted tape cassette 14 is accessible to the user upon opening a tip cover 18.
  • the tape cassette 14 serves as a test magazine, as a plurality of test elements 20 is provided on a spoolable transport tape for successive use on the tip 16.
  • the handheld meter 12 is provided with a photometric measuring unit 22 and a processor unit 24 (electronic micro-processor) for determining the concentration of the analyte from the measured values.
  • the measuring result and other information can be displayed to the user on a display 24.
  • the meter 12 is further provided with a proximity sensor 28 to detect the presence of a body part during critical measuring phases, thus allowing to control user handling.
  • a lancing aid 30 is attached to the meter 12 for simplifying lancing of a body part in order to sample blood.
  • Fig. 2 depicts a handling situation in a partial cross section of the system 10 transverse to the tip 16 of the inserted tape cassette 14.
  • the user applies a drop of blood from his finger 32 to a top side of the active test element 22 provided on the tip 16.
  • the test element 22 is formed by a layered chemistry field on the transport tape 34 which is responsive to the analyte by a color change.
  • the measuring unit 22 provided as a reflectometer allows a measurement of the analyte concentration by optical scanning the rear side of test element 22 through the transparent transport tape 34.
  • the measurement may be biased by the presence of the finger 32 which appears to the reflectometer as a dark background behind the incompletely opaque chemistry field. This influence increases with decreasing distance to the critical test field area.
  • continued finger pressure on the test element 22 after sample application may lead to an unwanted modification of the layered test structure, specifically if a covering net provided for sample spreading is impressed into the chemistry field such that the optical measurement is impaired thereby.
  • the proximity sensor 28 is configured to sense the presence of the body portion in a monitored space 36 in proximity to the test element 22.
  • the proximity sensor 28 is placed laterally to the tape 34 adjacent to the tip 16.
  • the favored solid angle that will be surveilled by the proximity sensor 28 should be as much as possible restricted. It should be ensured that the sensor does not detect objects outside a specified detection area, especially any support surface like e.g. a table. Ideally, the monitored space 36 should include a cuboid in the size of approximately 3 x 3 x 10 mm, where the long side of the cuboid is perpendicular to the top side of the test element 20. Furthermore, the optical analyte measuring unit 22 should not be disturbed by the proximity sensor 28.
  • the proximity sensor 28 should deliver a digital signal indicating solely the following cases:
  • the proximity sensor 28 may be formed as a kind of photometric sensor that can detect any kind of object.
  • the working principle may be similar to that of the analyte measuring unit: Somehow modulated light is send out by a light source (LED). Any reflected light is collected by a photo detector. Depending on the amount of reflected light an analog signal is created. Via a set threshold the digital discrimination between absence and presence of an object is made.
  • the measuring process may be divided in various measuring phases.
  • the time diagram shows measuring values on a test element provided by using a main light source (symbol x) and at least one auxiliary light source (symbol o) of the measuring unit 22.
  • a blank value is detected as a double-measurement on the yet unused test element 20 prior to sample application.
  • the auxiliary light source is powered to enable wetting detection preferably at a different wavelength.
  • consecutive measuring values are registered with a given sampling rate of e.g. 5 Hz to enable recognition of the wetting of the test element 22 due to sample application by the user. Such wetting leads to a signal decrease below a predetermined detection threshold.
  • a predetermined waiting time should be observed in phase III.
  • phase IV the chemical reaction due to the presence of the analyte can be tracked in phase IV, where the reaction product leads to an increasing darkening and hence to less reflected light.
  • the kinetic curve exhibits an asymptotic behavior, such that a given stop criterion is reached after a plurality of measurement readings.
  • phase V an end value is recorded, eventually followed by a control measurement for sufficiency of sample application.
  • the analyte concentration value is determined from the ration of the end value to the blank value. All other measurements are only accessory to find this result.
  • Fig. 3 also shows a comparative measurement with intended use, i.e. absence of a body part 32 after the waiting time (upper curve associated with the dotted arrow shown in phase III), and with non-intended use, i.e. presence of the body part 32 (lower kinetic curve and continuous arrow in phase III). Associated therewith, the digital output signal of the proximity sensor 28 is shown below in dotted and continuous lines. It becomes readily apparent that the presence of the body part after sample application leads to a reduced background remission, which interferes the measuring result quite remarkably.
  • the information obtained by the proximity sensor 28 in the meter 12 is processed differently during various measurement phases. If possible, appropriate feedback (visual, acoustic and/or haptic) is provided to the user, as explained in more detail below.
  • Fig. 4 shows a flow-chart of a signal processing routine of the processing unit 24 in phase I when measuring the blank value.
  • the blank value can be determined without bias of the measuring unit 22.
  • the blank value cannot be determined reliably and an error message is displayed as a feedback to the user.
  • Fig. 5 shows another operational principle of the signal processing routine (measuring engine) running in the processing unit 24 in phase III.
  • the kinetic curve tracking is accomplished when the object (body portion) is not present in the monitored space.
  • the presence of the body portion may be tolerated for a given elapsed time since the wetting detection.
  • the user can be warned to remove his finger, such that the active test element 20 needs not to be discarded. Thereafter, an error message is displayed and the measurement is aborted.
  • both the output signal of the proximity sensor 28 and the measuring values of the measuring unit 22 have to be supplied to the processing unit 24 for sequential or parallel processing. Furthermore, the processing unit 24 must be configured for evaluation of a duration of the proximity signal.
  • a second confirmation of the blood application may be obtained by an evaluation of the proximity signal. This may be obtained comparing the digital proximity signal with empirical data for duration of object detection during wetting stored in a memory of the meter 12.
  • Another option to employ the proximity sensor 28 would be to stop the tape transport while object recognition is positive to ensure a correct positioning of the test elements in the respective active position on the tip 16.

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Claims (15)

  1. Verfahren zur Bestimmung einer Analytkonzentration in einer Körperflüssigkeit umfassend die Schritte
    a) Bereitstellen eines Einweg-Testelements (20) an einer Applikationsstelle in einem Handmessgerät (12),
    b) Vorlegen einer Körperflüssigkeit auf einem Körperteil eines Benutzers (32) und Applizieren der Körperflüssigkeit auf einen Reaktionsbereich des Testelements (20),
    c) Detektieren einer Reihe von Messwerten an dem Reaktionsbereich des Testelements (20) mittels einer vorzugsweise photometrischen Detektionseinheit (22) des Messgerätes (12), und Bestimmen der Analytkonzentration zumindest zum Teil aus der Reihe der Messwerte,
    d) Verwenden eines in dem Messgerät (12) angeordneten Näherungssensors (28), um die Präsenz des Körperteils (32) in einem überwachten Raum (36) in der Nähe des Reaktionsbereichs des Testelements (20) zu erfassen, und
    e) Steuern der Verarbeitung der Messwerte in Abhängigkeit von einem Ausgangssignal des Näherungssensors (28), um eine durch die Präsenz des Körperteils (32) verursachte Messabweichung bei der Bestimmung der Analytkonzentration zu vermeiden.
  2. Verfahren nach Anspruch 1, bei dem bei Erfassung der Präsenz des Körperteils (32) in dem überwachten Raum (36) eine Warnung an den Benutzer ausgegeben wird.
  3. Verfahren nach Anspruch 1 oder 2, bei dem die Erfassung von Messwerten abgebrochen wird und/oder eine Fehlermeldung durch das Messgerät (12) ausgegeben wird, wenn die Präsenz des Körperteils (32) in dem überwachten Raum (36) beobachtet wird.
  4. Verfahren nach einem der Ansprüche 1 bis 3, ferner umfassend
    Messen eines Zeitintervalls der Präsenz des Körperteils (32) in dem überwachten Raum (36), und Abbrechen der Erfassung von Messwerten und/oder Ausgeben einer Fehlermeldung an den Benutzer nach einer vorbestimmten Länge des Zeitintervalls.
  5. Verfahren nach Anspruch 4, wobei eine Benetzung des Testelements (20) mit Körperflüssigkeit erfasst wird, und die Messung des Zeitintervalls zu dem Zeitpunkt gestartet wird, zu dem die Benetzung erfasst wird.
  6. Verfahren nach Anspruch 4 oder 5, wobei die Dauer des Zeitintervalls im Bereich von 0,5 bis 2 s liegt.
  7. Verfahren nach einem der Ansprüche 1 bis 6, wobei die Erfassung der Messwerte nur dann abgeschlossen wird, wenn sich das Körperteil (32) nicht im überwachten Raum (36) befindet.
  8. Verfahren nach einem der Ansprüche 1 bis 7, bei dem das Ausgangssignal des Näherungssensors (28) während der Verarbeitung der Messwerte als Eingang für eine Prozessoreinheit (24) des Messgeräts (12) zur Verfügung gestellt wird.
  9. Verfahren nach einem der Ansprüche 1 bis 8, wobei das Ausgangssignal des Näherungssensors (28) während mindestens zwei verschiedenen Zeitperioden während der Erfassung der Messwerte unterschiedlich verarbeitet wird.
  10. Verfahren nach einem der Ansprüche 1 bis 9, ferner umfassend
    Konfigurieren des Näherungssensor (28) derart, dass der überwachte Raum (36) einen Quader mit einer Größe von mindestens 1 x 1 x 5 mm, vorzugsweise mindestens 3 x 3 x 10 mm, umfasst, wobei die lange Seite des Quaders senkrecht zu einer Oberfläche des Testelements (20) ist.
  11. Verfahren nach einem der Ansprüche 1 bis 10, wobei das Ausgangssignal des Näherungssensors (28) als digitaler Wert bereitgestellt wird, der nur die Präsenz oder das Fehlen des Körperteils (32) in dem überwachten Raum (36) angibt.
  12. Verfahren nach einem der Ansprüche 1 bis 11, wobei die Erfassung von Messwerten eine anfängliche Messphase zum Messen eines Leerwertes auf dem Testelement (20) vor der Applikation von Körperflüssigkeit, eine Zwischenmessphase zum Verfolgen eines Verlaufs der Messwerte und eine Endmessphase zum Bestimmen eines für eine Quantität des Analyten charakteristischen Endwertes umfasst.
  13. Verfahren nach einem der Ansprüche 1 bis 12, weiterhin umfassend Transportieren des Testelements (20) auf einem Transportband über eine Umlenkspitze (16) als Probenapplikationsstelle, und Anordnen des Näherungssensors (28) neben oder im Nachbereich der Umlenkspitze (16).
  14. Verfahren nach einem der Ansprüche 1 bis 13, bei dem die Körperflüssigkeit auf eine frei zugängliche Applikationsseite des Testelements (20) aufgetragen wird, und die Messwerte durch Abtasten einer Rückseite des Testelements (20) gegenüber der Applikationsseite erfasst werden.
  15. Analytkonzentrationsmessvorrichtung, insbesondere zur Blutzuckerbestimmung, umfassend ein Handmessgerät (12), das dazu eingerichtet ist, ein einen Reaktionsbereich an einer Applikationsstelle zum Aufbringen von Körperflüssigkeit aus einem Körperteil (32) eines Benutzers aufweisendes Einweg-Testelement (20) bereitzustellen, eine zum Erfassen von Messwerten an dem Reaktionsbereich des Testelements (20) betreibbare, vorzugsweise photometrische Erfassungseinheit (22), und einen in dem Messgerät (12) angeordneten Näherungssensor (28) zur Erfassung der Präsenz des Körperteils (32) in einem überwachten Raum (36) in der Nähe des Reaktionsbereichs des Testelements (20), wobei eine Prozessoreinheit (24) des Messgeräts (12) konfiguriert ist für
    i) Verarbeiten der Messwerte zur Bestimmung der Analytkonzentration, und
    ii) Verarbeiten der Messwerte in Abhängigkeit von einem Ausgangssignal des Näherungssensors (28), um eine durch die Präsenz des Körperteils (32) verursachte Messabweichung bei der Bestimmung der Analytkonzentration zu vermeiden.
EP17793905.5A 2016-10-25 2017-10-24 Verfahren zur bestimmung einer analytkonzentration in einer körperflüssigkeit und analytkonzentrationsmessvorrichtung Active EP3531913B1 (de)

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EP16195524.0A EP3315069A1 (de) 2016-10-25 2016-10-25 Verfahren zur bestimmung einer analytkonzentration in einer körperflüssigkeit und analytkonzentrationsmessvorrichtung
PCT/EP2017/077137 WO2018077863A1 (en) 2016-10-25 2017-10-24 Method for determination of an analyte concentration in a body fluid and analyte concentration measurement device

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US (1) US11284817B2 (de)
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JP (1) JP7141392B2 (de)
KR (1) KR102252241B1 (de)
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CA3040979C (en) 2021-10-05
EP3531913A1 (de) 2019-09-04
TW201821796A (zh) 2018-06-16
JP2020500300A (ja) 2020-01-09
KR20190053258A (ko) 2019-05-17
CN109922730A (zh) 2019-06-21
WO2018077863A1 (en) 2018-05-03
CA3040979A1 (en) 2018-05-03
JP7141392B2 (ja) 2022-09-22
EP3315069A1 (de) 2018-05-02
US11284817B2 (en) 2022-03-29
KR102252241B1 (ko) 2021-05-14
US20190239781A1 (en) 2019-08-08
CN109922730B (zh) 2022-03-22
TWI766894B (zh) 2022-06-11

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